Neoadjuvant Hormone and Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk Prostate Cancer

What Was Tested

The trial (not phased) is built around Goserelin.

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.

Androgens can stimulate the growth of prostate cancer cells.

Hormone therapy can fight prostate cancer by androgen deprivation.

It had two arms (groups): Neoadjuvant RT and ADT (experimental) and Neoadjuvant ADT (active comparator).

The registry classes the interventions as drug, procedure and radiation.

More on the Plan

Success rate of salvage radiation therapy (SRT) measured as pathologic complete response (pCR) or pathologic near complete response (minimal residual disease, MRD) rate.

PSA decline rate after neoadjuvant treatment, rate of undetectable PSA after RP, rate of positive surgical margin, and rate of pathologic down-staging (≤ ypT2N0) II.

Biochemical recurrence-free survival rate (from date of randomization).

Overall Survival OUTLINE: Participants are randomized to 1 of 2 arms.

Who Took Part

38 planned participants were the target.

It was open to men only aged from 20 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men with age from 20 to 75 years old. Histologically confirmed adenocarcinoma of the prostate. High-risk locally advanced disease defined by ≥1 of the following 3 criteria:. T3a-3b by DRE or MRI. Gleason score ≥ 8 (= Grade group 4).

The full record lists 9 inclusion and 14 exclusion criteria; among the exclusions: pathological finding of small cell, ductal or neuroendocrine carcinoma; current or prior hormone therapy, radiotherapy, or chemotherapy; evidence of metastasis (m1) on images.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Goserelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Goserelin study did not mask who received what.

It started in 2022-01-27 with completion listed for 2024-07-01.

It ran at 2 sites in Taiwan (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Pathologic outcome (time frame: From date of randomization to the date of radical prostatectomy, up to 100 weeks).

It also tracked 7 secondary outcomes, for example PSA decline percentage, PSA complete response rate, PSA Recurrence, Distant Failure, Overall Survival and Progression-free Survival.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Goserelin in 38 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, all human trials.